FDA’s Food Traceability Rule under FSMA Section 204 is designed to help FDA trace certain foods through the supply chain faster during an outbreak, recall, or other public-health event.
The original compliance date was January 20, 2026. Congress has directed FDA not to enforce the rule before July 20, 2028, giving covered businesses additional time to prepare.
That does not mean companies should wait until 2028 to begin.
Who Needs to Prepare?
The rule applies to businesses that manufacture, process, pack, or hold foods appearing on FDA’s Food Traceability List (FTL), subject to applicable exemptions and partial exemptions.
The FTL includes categories such as:
- Certain fresh produce
- Fresh-cut produce
- Leafy greens
- Certain cheeses
- Shell eggs
- Nut butters
- Certain seafood
- Deli salads
The rule can also apply to foods containing an FTL food as an ingredient when the listed food remains in the same form in which it appears on the FTL.
Understand the CTEs and KDEs
The foundation of FSMA 204 is the connection between Critical Tracking Events (CTEs) and Key Data Elements (KDEs).
CTEs can include activities such as:
- Shipping
- Receiving
- Transformation
- Initial packing
- First land-based receiving of certain seafood
For each applicable event, the business must maintain the required KDEs and connect those records to the relevant traceability lot.
The goal is not simply to collect more data. The goal is to make each lot traceable through the supply chain.
Start With the Traceability Lot Code
A major requirement is the Traceability Lot Code (TLC).
A TLC uniquely identifies a traceability lot within the records of the business assigning it. Once assigned, the TLC generally follows the food through the supply chain unless the food is transformed.
Companies should determine now:
- Where TLCs are assigned
- Who assigns them
- How they are structured
- How the TLC is connected to KDEs
- How the TLC is communicated to supply-chain partners
The TLC does not have to be printed on the product label. It can be communicated through documents, electronic systems, shipping information, or other appropriate methods.
Build Your Traceability Plan
Covered businesses must establish and maintain a Traceability Plan.
The plan should explain:
- How required records are maintained
- Where records are stored
- How FTL foods are identified
- How TLCs are assigned, when applicable
- Who is responsible for traceability records
Certain farms also have additional farm-map requirements.
Your traceability plan should reflect what the company actually does—not simply copy a generic template.
Work With Your Supply Chain Now
One of the biggest implementation challenges is that traceability depends on information moving between companies.
Your suppliers and customers may need to provide information that your own system does not currently capture.
Before July 2028, companies should:
- Identify affected suppliers and customers
- Determine what KDEs each partner can provide
- Standardize data fields where possible
- Review purchase orders and shipping documents
- Test electronic data exchange
- Resolve gaps in lot-level information
FDA has specifically identified supply-chain coordination and lot-level tracking as important implementation issues.
Test Your System Before the Deadline
Do not wait for the compliance date to discover that your records cannot trace a lot.
Run a mock traceability exercise:
Pick one FTL product → identify its lot → trace it backward to its source → trace it forward to every recipient → document how long the process takes.
Then test whether you can produce the required information in the format FDA expects.
Covered records generally must be made available to FDA within 24 hours of a request, or within another reasonable time agreed with FDA. An electronic sortable spreadsheet may also be required during an outbreak, recall, or other public-health situation.
A Practical 2026–2028 Preparation Plan
2026 — Assess
Determine whether your products and operations fall under the FTL and identify applicable exemptions.
2027 — Build
Develop the traceability plan, define CTE/KDE requirements, establish TLC procedures, and update systems.
Early 2028 — Test
Run mock recalls and lot-tracing exercises with suppliers and customers.
Before July 20, 2028 — Close gaps
Correct missing data, train employees, finalize procedures, and confirm that records can be retrieved quickly.
Bottom Line
July 20, 2028 should be treated as a deadline for readiness, not the start of preparation.
Companies handling FTL foods should use the additional time to map their supply chain, identify required CTEs and KDEs, establish TLC procedures, build their Traceability Plan, and test their ability to trace a lot from source to recipient.
A traceability system that works on paper but fails during a real recall is not enough.
JJCC Group can help food companies assess FSMA 204 applicability, map CTEs and KDEs, develop traceability procedures, and prepare for the July 20, 2028 compliance date.
